BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    SPQ TEST SYSTEM FOR HAPTOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515224353·Pterygo-Masseteric Sling Stripper, Rt, 6.5mm, 9"

    GS-128 GRADIENT COMPRESSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Stryker Suture Tape

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    S-ICD SYSTEM

    FDA Adverse Event
    Injury ·CAMERON HEALTH INC·Product code LWS·May 22, 2014

    SJM MASTERS SERIES MECHANICAL HEART VALVE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO, INC. (CS)·Product code LWQ·November 16, 2012

    XENIUM 190G SYNTH HF DIALYZER

    FDA Adverse Event
    Malfunction ·NIPRO CORPORATION USD·Product code KDI·October 1, 2010

    COBAS 6000 C (501) MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 21, 2025

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021